Job Description

Locations

• India, Bengaluru

Skills Required

• Regulatory Affairs within the medical deviceintermediate
• regulatory requirements for Hong Kongintermediate
• technical documentationintermediate
• ASEAN medical device regulationsintermediate
• UDIintermediate

Required Qualifications

• · Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline. (degree in master)
• · Experience - 5 years- 7 years and relevant 3 years of experience in Regulatory Affairs within the medical device, healthcare, pharmaceutical, or life sciences industry. (experience, 5 years)
• · Experience supporting product registrations, renewals, amendments, and lifecycle management activities across APAC markets; supporting NPI and sustaining engineering activities from a regulatory perspective; working with regulatory information management systems, PLM systems, document control systems, or equivalent tools is preferred. (experience)
• · Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan, or other international medical device markets. (experience)
• · Familiarity with technical documentation, design control, change control, and product lifecycle management processes. (experience)
• · Strong understanding of global regulatory frameworks and quality management principles applicable to medical devices. (experience)
• · Ability to perform regulatory impact assessments and independently determine submission strategies for changes. (experience)
• · Strong analytical, problem-solving, organisational, and project management skills. (experience)
• · Excellent written and verbal communication skills with the ability to collaborate effectively across global teams. (experience)
• · Ability to manage multiple priorities with minimal supervision in a fast-paced environment. (experience)

Preferred Qualifications

• · Knowledge of ASEAN medical device regulations and international regulatory requirements. (experience)
• · Experience working with distributors, local country representatives, and external regulatory partners; global product portfolios and cross-regional regulatory initiatives. (experience)
• · Familiarity with UDI, product registration databases, and post-market regulatory processes. (experience)

Responsibilities

• · Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan.
• · Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications in accordance with local regulatory requirements.
• · Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes and determine required regulatory actions.
• · Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance with applicable regulations and market requirements.
• · Coordinate with regional regulatory teams, distributors, and in-country representatives to support regulatory submissions and market access activities.
• · Monitor regulatory commitments, submission timelines, approval status, and renewal requirements to ensure uninterrupted product availability.
• · Review technical documentation, product information, labelling, and other supporting records for completeness, accuracy, and regulatory compliance.
• · Support post-market regulatory activities, including field actions, vigilance-related submissions, product updates, and compliance requests as required.
• · Maintain regulatory records, databases, and document repositories in accordance with internal procedures and document control requirements.
• · Track changing regulatory requirements within assigned markets and assess the impact on existing products and planned product launches.
• · Collaborate with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain teams to obtain required documentation and support regulatory deliverables.
• · Independently manage multiple projects and priorities while delivering high-quality regulatory outputs within established timelines.
• · Identify opportunities for process improvements, standardization, and efficiency enhancement across APAC regulatory activities.
• · Support internal and external audits, inspections, and compliance assessments by providing regulatory documentation and subject matter expertise.
• · Proactively communicate project risks, regulatory concerns, and potential market access impacts to stakeholders and management.

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